The FDA and U.S. Customs and Border Protection (CBP) require the use of electronic data submission and strict accuracy. The FDA’s data programs interact in real-time with CBP’s. The detention process operates with remarkable efficiency. If you get into trouble, you must know what you can and cannot do. Time is not on your side. Fines and seizures may be your next concerns. If the FDA “refuses” your entry, there is no appeal. The FDA’s import process is complex and detailed and subject to an enforcement process that can become prohibitively expensive for conducting ongoing business. Seemingly small errors can derail your business plans. When and how you manage your operations and computer database makes a significant difference in the success or failure of your import operations and net profits.  

For the past several months, the FDA has issued Warning Letters under the Voluntary Qualified Import Source (VQIS) program. The outcome can dismantle a firm’s import business. The benefit of expedited entry under the VQIS program is lost and recovering from that loss may create survivability issues for near-term business plans.

Learning Objectives:-

• Identify required FDA and CBP information to begin the import entry process.
• When to submit entry information
• Understand how the information is used.
• Identify product identification problems.
• What happens with the detention of an entry?
• Understand Warning Letters issued to Voluntary Import Qualification Program participants.

Areas Covered:-

• The FDA’s statutory authority
• Integrated operations of the FDA and CBP
• When to submit information
• Managing Detentions
• Managing Voluntary Qualified Import Source Warning Letters

Background:-

The FDA, in conjunction with the U.S. Customs and Border Protection (CBP), is responsible for making sure regulated products coming into the U.S. meet our domestic requirements, such as safety, effectiveness, and labeling. The FDA and CBP work concurrently when you present a product for entry into the U.S. They share their database and alerts. Unless you satisfy the FDA’s detailed entry requirements, CBP will not release your products for entry. You either fix, destroy, or re-export that entry. 

Who Should Attend:-

• Business Planning Executives
• Regulatory Directors
• In-house Legal Counsel and Contract Specialists
• Venture Capitalists
• Business Acquisition Managers
• Owners of New or Developing Import Firms
• International Trade and Logistics Managers
• Import Brokers
• Investors
• Sales Managers